Preventive Effect of Diospyros kaki on Intraocular Pressure and Dry Eye: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

BackgroundDry eye disease (DED) is a common chronic ocular disorder associated with ocular discomfort and tear film damage. Traditional medicinal uses of Diospyros kaki leaves have been well-documented for their potent radical-scavenging, antioxidant, and immune-modulatory properties. Emerging evidence suggests that D. kaki leaves can improve various ocular conditions, including dry eye disease and elevated intraocular pressure (IOP), making it a potential therapeutic option for managing these conditions. MethodsA randomized controlled trial was conducted involving one hundred patients diagnosed with mild DED. The participants were divided into placebo and treatment groups, receiving maltodextrin and EEDK (600 mg/day). Clinical efficacy, clinical indices, and adverse reactions were compared between the two groups. ResultsAdministration of EEDK significantly improved tear film stability and corneal staining scores in patients with DED. IOP significantly decreased after EEDK administration. The EEDK group exhibited significant improvements in tear film stability compared with the placebo group at 4, 8, and 12 weeks. Consistent reductions in IOP and corneal staining scores were observed throughout the 12-week study period in the EEDK group. Moreover, EEDK intake effectively enhanced tear production as evidenced by the Schirmer test. No significant adverse events were observed. ConclusionsThe oral administration of EEDK demonstrated significant therapeutic effects in improving dry eye symptoms without notable adverse events. The results of this study suggest that EEDK could be considered an ideal therapeutic option for treating patients with dry eye disease. Trial registrationThe trial is registered with the Korean Clinical Trial Registry, KCT0010532 Highlights- Ethanol extract of Diospyros kaki (EEDK) improves dry eye symptoms and tear film stability. - EEDK significantly reduces intraocular pressure in patients with dry eye disease. - Randomized, double-blind, placebo-controlled clinical trial conducted over 12 weeks. - No significant adverse events observed, indicating EEDK is well-tolerated. Graphical abstract O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=151 SRC="FIGDIR/small/25331959v1_ufig1.gif" ALT="Figure 1"> View larger version (36K): org.highwire.dtl.DTLVardef@13d8b48org.highwire.dtl.DTLVardef@1833711org.highwire.dtl.DTLVardef@194743borg.highwire.dtl.DTLVardef@15b08c5_HPS_FORMAT_FIGEXP M_FIG C_FIG